Millions of individuals suffer from either partial or total loss of walking ability, resulting in greatly impaired mobility for the affected individual. This disabled state can result from traumatic injury, stroke, or other medical conditions that cause disorders that affect muscular control. Regardless of origin, the onset and continuance of walking impairment can result in additional negative physical and/or psychological outcomes for the stricken individual. In order to improve the health and quality of life of patients with walking impairment, the development of devices and methods that can improve or restore walking function is of significant utility to the medical and therapeutic communities. Beyond walking impairment, there are a range of medical conditions that interfere with muscular control of the appendages, resulting in loss of function and other adverse conditions for the affected individual. The development of devices and methods to improve or restore these additional functions is also of great interest to the medical and therapeutic communities.
Human exoskeleton devices are being developed in the medical field to restore and rehabilitate proper muscle function for people with disorders that affect muscle control. These exoskeleton devices include a system of motorized braces that can apply forces to a wearer's appendages. In a rehabilitation setting, exoskeletons are controlled by a physical therapist who uses one of a plurality of possible input means to command an exoskeleton control system. In turn, the exoskeleton control system actuates the position of the motorized braces, resulting in the application of force to, and typically movement of, the body of the exoskeleton wearer. Exoskeleton control systems prescribe and control trajectories in the joints of the exoskeleton. These trajectories can be prescribed as position-based, force-based, or a combination of both methodologies, such as that seen in an impedance controller. Position-based control systems can modify exoskeleton trajectories directly through modification of the prescribed positions. Force-based control systems can modify exoskeleton trajectories through modification of the prescribed force profiles. Complicated exoskeleton movements, such as walking, are commanded by an exoskeleton control system through the use of a series of exoskeleton trajectories, with increasingly complicated exoskeleton movements requiring increasingly complicated series of exoskeleton trajectories. These series of trajectories may be cyclic, such as the exoskeleton taking a series of steps with each leg, or they may be discrete, such as an exoskeleton rising from a seated position into a standing position.
During a rehabilitation session and/or over the course of rehabilitation, it is highly beneficial for the physical therapist to have the ability to modify the prescribed positions and/or the prescribed force profiles depending on the particular physiology or rehabilitation stage of the patient. It is highly complex and difficult to construct an exoskeleton control interface that enables the full range of modification desired by a physical therapist during rehabilitation. In addition, it is important that the control interface not only allow the full range of modifications that may be desired by the physical therapist but also that the interface with the physical therapist be intuitive to the physical therapist, who may not be highly technically oriented. Even given an optimal control interface, certain physical therapists will be more skilled at creating exoskeleton trajectory sequences than others, and it is self-evident that an exoskeleton trajectory sequence produced by one physical therapist might be of use to a different physical therapist, even if only as a starting point for producing a modified trajectory sequence for a specific patient at a particular point in rehabilitation.
As exoskeleton design, control systems, and trajectory sequences improve, medical exoskeleton use will progress from use in rehabilitation settings to use by disabled individuals outside of rehabilitation. While the trajectory sequences used in rehabilitation are quite suitable for use in exoskeletons designed to increase the user's mobility (e.g., wheelchair replacement with an ambulatory exoskeleton), it should be recognized that if an exoskeleton can be made to allow a wearer to walk, then an exoskeleton can be made to allow a wearer to engage in more complicated activities such as dance or sports. However, the exoskeleton trajectories required for the highly complicated motions involved in such activities will be non-trivial to create and sequence, requiring the construction of these exoskeleton trajectory sequences by skilled physical therapists or other exoskeleton trajectory creators, likely with a substantial expenditure of time and labor. Once these complicated exoskeleton trajectory sequences have been created, it would be beneficial to other exoskeleton wearers or physical therapists to have access to the trajectory sequences. Similarly, advanced trajectory sequences may also soon be of use to able-bodied individuals for training and/or augmentation functions.
Methods have previously been developed that allow current exoskeletons to transmit exoskeleton trajectory information to a central server, such as EKSO PULSE™. However, a reverse system, in which trajectory information is transmitted from a central server to an exoskeleton control system, carries significant risks: an exoskeleton joint might be commanded to move outside of a safe range of motion; an exoskeleton might apply too much acceleration to an exoskeleton wearer; or unsafe trajectories may unbalance an exoskeleton, resulting in injury to the exoskeleton wearer. Moreover, it must further be considered that what is safe for one specific exoskeleton wearer may not be safe for another, depending on the wearer's mass and proportions, extent of disability/rehabilitative state, and skill level at exoskeleton operation—with these considerations in some cases requiring modification of trajectories for different users. Furthermore, the United States Food and Drug Administration (FDA) requires that medical devices be proven to be safe, and, as such, the safety of exoskeleton trajectory packages should be clearly and consistently demonstrated.
Accordingly, there exists an unmet need to develop a method and device that allows for exoskeleton trajectory sequence creators to be able to distribute, with satisfaction of certain terms including payment, exoskeleton trajectory sequences to other exoskeleton users. There also exists an unmet met need to provide a method and device that demonstrates, to the satisfaction of applicable regulatory authorities, that the exoskeleton trajectory sequences considered for distribution are safe. As such, the distribution system preferably also includes a validation component, including but not limited to a safety check of the exoskeleton trajectory sequence, prior to the transfer of a trajectory sequence to a new exoskeleton/exoskeleton user.